Compositions comprising extracts of boswellia, tea tree, aloe and lavender oil and methods of treating wounds, burns and skin injuries therewith

ABSTRACT

Compositions for the treatment of sores, wounds, burns and other traumatized dermal tissues and skin injuries comprising  Boswellia  gum, gel, resin or extract, Tea Tree oil ( Melaleuca  oil), an  Aloe  gel, resin, latex or extract and Lavender oil. The composition may be incorporated into a medical device such as a wound dressing or bandage, or formulated into a topical preparation such as an ointment, lotion or cream.

FIELD OF INVENTION

The present invention relates to generally to compositions for thetreatment of sores, wounds, burns and other traumatized dermal tissuesand skin injuries. More specifically, the present invention relates tocompositions comprising plant extracts, medical devices incorporatingthese compositions, and methods of treating sores, wounds, burns andother traumatize dermal tissues and skin injuries therewith.

BACKGROUND OF THE INVENTION

Wound healing is a complex process that some researchers divide into 3phases of evolution: inflammatory phase, proliferation, and remodeling(1). The inflammatory phase is the first response to an injury andinvolves multiple responses that include both a cellular andchemokine/cytokine response. The response includes blood coagulation,infiltration of leukocytes, etc. This first phase of response leads tothe initiation of the proliferative response for wound healing. In fact,these two first phases overlap and multiple factors influence thephases. An important part of the proliferative phase is the formation ofepithelium to cover the wound surface. The epithelialization reactionoccurs somewhat in parallel to the growth of granulation tissue that isrequired to fill the wounds “empty” space. According to Li et al (1),the granulation tissue formation is the result of the proliferation offibroblasts deposition of collagens and other materials along with anangiogenic process for the formation of new blood vessels. Finally, thethird phase is a remodeling phase that involves restoring the structuralintegrity and functional aspects of the site (1). Every phase of thewound healing process can be influenced by factors such as infection,that will either increase the tissue damage and/or prolong the healingtime, as well as dead skin, bleeding, mechanical damage (compression oftissue and friction), dryness, etc.

There are several types of wounds, but they can generally be summarizedas either acute or chronic. Acute wounds normally heal without delay andcomplications, and include burns, traumatic injuries and surgicalwounds. Chronic wounds are those that involve a disruption of the woundhealing process that results in consequences such as a prolonged time toheal, recurrence or simply non-healing (1). Chronic wounds includevenous leg ulcers, pressure sores/ulcers, ischemic ulcers, diabeticulcers, etc.

Management of Wounds

Each wound is unique and multiple factors influence the methods used tohelp heal. These factors include the location and size of the injury,the type of injury (e.g. incision, burn), depth of the wound and othertissues involved in injury (i.e., nerves), foreign material in the woundas well as infection, complications during healing that prolong healingtime, and genetic or pathophysiological factors influencing thedifferent parameters of healing.

The type of wound closure plays a major role in the healing process.Closure by primary intent is defined as wound closure immediatelyfollowing the injury and prior to the development of the granulationtissue. Healing by primary intent ultimately leads to the fastesthealing and optimal cosmetic result. Closure by secondary intent isdefined as the process where wounds heal on their own without surgicalclosure. Closure by tertiary intent is defined as a first treatmentphase where the wound is cleaned and dressings are applied and a secondphase several days later for wound closure.

Methods of treating a wound may include one or more steps as necessaryto facilitate healing, prevent infection and complications, limitscarring and hyperpigmentation, etc. Treatment may include cleaning thewound to remove foreign material; removing dead skin; closing (in thecase of large wounds) with stitching type materials (e.g., sutures);dressing the wound; relieving pain; and treating signs of infection.

In the case of chronic wounds such as pressure or diabetic ulcers,additional treatments may be required. These are generally aimed attrying to improve blood flow to the site of injury to promote healing ofthe wound/ulcer. Methods involving the use of absorbent dressings andcompression bandages typically help improve blood flow.

In addition to the above treatment methods, various substances, bothnaturally occurring and synthetic, may be employed to promote healing ofskin tissues. These are often applied directly to the area of the woundor sore in the form of a lotion or ointment, or incorporated into abandage, dressing or other device to promote healing while the device isin use.

For example, U.S. Pat. No. 5,266,318 describes a composition fortreatment of irradiated skin, open sores, wounds and abrasions. Thiscomposition is comprised of an aloe vera gel extract, allantoin andlavender essential oil.

Another composition for the treatment of wounds and related conditionsis described in U.S. Pat. No. 5,879,717, which is comprised of a sugar,iodine and a glycol or water vehicle, and is specifically designed foruse in veterinary medicine.

A further composition, which is described in U.S. Pat. No. 5,980,875, isprepared by mixing honey with oil, a gelling agent, an emulsifier andother components, and is used for the treatment of Herpes, cold sores,burns, skin allergies and other wounds.

Additionally, U.S. Pat. No. 6,099,866 describes a combination of beeswaxwith oil and optionally water to produce a composition for treatment ofvarious burns and abrasions.

As can be seen, numerous compositions and combinations are known toassist in the treatment and healing of wounds and skin injury.Nevertheless, research continues in this area in order to develop newcompositions with improved effectiveness and/or reduced side-effects.

SUMMARY OF THE INVENTION

An object of the invention is therefore to provide compositions andmethods for treating sores, wounds, burns and other traumatized dermaltissues and skin injuries.

The invention accordingly relates to compositions comprising plantextracts useful for treating sores, wounds, burns and other traumatizeddermal tissues and skin injuries, as well as medical devices comprisingsuch compositions.

In certain non-limiting embodiments the medical device may be a dressingor a bandage, or may comprise a slow-release polymer, alginate,oligosaccharides (poly-), chitin, or hydrocolloids.

The invention also relates to methods for treating sores, wounds, burnsand other traumatized dermal tissues and skin injuries in a subject,comprising administering a composition or medical device as describedherein. Preferably, treating a subject with a composition or medicaldevice as defined herein results in at least partial healing oramelioration of the sore, wound, burn or other traumatized dermal tissueor skin injury.

In an embodiment of the invention, the composition comprises Boswelliagum, gel, resin or extract, Tea Tree oil (Melaleuca oil), Aloe gel,resin, latex or extract and Lavender oil.

Without wishing to be limiting, the Boswellia gum, gel, resin or extractmay be derived from the leaves, plant or roots of Boswellia serrata orother species of Boswellia, such as Boswellia sacra or Boswelliacarterii. In a preferred embodiment, the composition comprises about 10%to 99% boswellic acids (e.g. as measured by UV-VIS spectrometryanalysis, HPLC Diode array or the like).

The Tea Tree oil (Melaleuca oil), which is also known as Australian teatree oil (Melaleuca alternifolia) may, in a further non-limitingembodiment, be derived from Melaleuca leaves, root or plant and maycontain more than >10% terpinene-4-ol (e.g. as measured by GC FID orECD).

The Aloe gel, resin, latex or extract (aqueous or alcoholic extract)may, in a further non-limiting embodiment, be derived from the leaves,root or plant of Aloe including, but not limited to Aloe vera, Aloeafricana, Aloe arborescens Miller, Aloe barbadensis, Aloe barbadesis,and Aloe capensis.

The Lavender oil may, in a further non-limiting embodiment, be derivedfrom the leaves, root, flower or plant of Lavandula officinalis oranother species of Lavender such as common lavender, English lavender,garden lavender, Lavandula angustifolia, Lavandula burnamii, Lavanduladentate, Lavandula dhofarensis, Lavandula latifolia, Lavandulaofficinalis, or Lavandula stoechas.

In further non-limiting embodiments, the compositions described hereinmay additionally comprise one or more components or extracts containinggrowth factors (including but not limited to growth factors fromcolostrum, whey, blood or tissue), antibiotics, analgesics, zinc oxide,vitamin A, vitamin E, extracts of Harpagophytum procumens (Devil's claw)root, Salix Alba (White Willow) plant and/or bark, Tanacetum Parthenium(Feverfew) herb and/or flower, Equisetum arvense (Horsetail), Spireaeulmaria (Dropwort), Betula alba (Birch), Urtica dioica (StingingNettle), Curcumin extract, longa (Tumeric), marine algae, or Gotu kola(Centella asiatica Linn.), total triterpenic fraction of Centellaasiatica (TTECA), or combinations thereof.

The present invention also provides a composition as described above,wherein the composition further comprises one or more components toabsorb wound exudates and/or slowly release the active herbalingredients. These components may include, but are not limited toalginate, hydrocolloid, chitin, polyoligosaccharides, liposome,slow-releasing polymers or agent, or combinations thereof.

The composition as described herein may, in further non-limitingembodiments, be formulated within or on the surface of a medical device.The medical device may be, in certain exemplary embodiments which arealso considered to be non-limiting, a dressing, bandage, or othersemi-occlusive or occlusive material commonly used in wound care. As anexample, the composition may be coated onto the medical device, orembedded or contained within particles or microparticles such asliposomes. For instance, the particles or microparticles comprising thecomposition as described herein may be used to deliver or release theactive herbal ingredients to the wound while maintaining semi-occlusionor complete occlusion.

As mentioned above, the present invention also relates to a method oftreating sores, wounds, burns and other traumatized dermal tissues andskin injuries. In certain non-limiting embodiments, the method involvestreating acute wounds, such as but not limited to heat and sun burns,traumatic injuries, surgical wounds, punctures, cracked heals, bites,insect bites and infected wounds. In other non-limiting embodiments, themethod involves treating chronic wounds, such as but not limited tovenous leg ulcers, pressure sores or ulcers, ischemic ulcers anddiabetic ulcers. When treating a surgical wound, in a non-limitingembodiment of the described method, the a composition or medical deviceas described herein may be administered to an incision which has beensutured, or to a wound which has been closed with surgical thread or thelike, in order to promote healing of the incision or wound.

According to the methods described herein, the subject may be amammalian subject, and in further non-limiting embodiments the subjectmay be a human.

This summary of the invention does not necessarily describe all featuresof the invention. In addition, those skilled in the art will recognize,or be able to ascertain using no more than routine experimentation,numerous equivalents to the specific procedures described herein. Suchequivalents are considered to be within the scope of this invention andare covered by the following claims.

BRIEF DESCRIPTION OF THE FIGURES

Further details of the invention will become apparent from the followingdescription, taken in combination with the appended figure wherein:

FIG. 1 illustrates a plot of the time course of wound healing in mousecutaneous injury model. Test substance was administered topically (TOP)once or twice or three times daily for 10 consecutive days. The woundclosure (%) was determined on days 3, 5, 7, 9 and 11, and then the woundhalf-closure time (CT₅₀) was obtained. One-way ANOVA followed byDunnett's test was applied for comparison between the treated andvehicle groups. *P<0.05, vs. vehicle.

DETAILED DESCRIPTION

Described herein are plant extracts which are useful for treating sores,wounds, burns and other traumatized dermal tissues and skin injuriestherewith. The described extracts can be provided in compositionstogether with an acceptable carrier, and/or together with one or moreseparate active agents. They can also be incorporated into a medicaldevice as described herein, or used in a method of treating sores,wounds, burns and other traumatized dermal tissues and skin injuries.

The following description is of a preferred embodiment.

According to the present invention, there is provided a compositioncomprising Boswellia gum, gel, resin or extract, Tea Tree oil (Melaleucaoil), an Aloe gel, resin, latex or extract and Lavender oil. Othercomponents may also be included as described herein and throughout.

In an embodiment, the Boswellia gum, gel, resin or extract is derivedfrom the leaves, plant or roots of Boswellia serrata, or other speciesof Boswellia such as Boswellia sacra, Boswellia carterii, and containsbetween about 10% and 99% boswellic acids, for example but not limitedto about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 99% or any valuetherein between. The amount of boswellic acids may also be defined by arange of any two of the values listed above or any value thereinbetween, and can be measured, for instance, by UV-VIS spectrometryanalysis, HPLC Diode array or other non-limiting method. More preferablythe Boswellia gum, gel, resin or extract contains between about 50% to79% boswellic acids.

The Tea Tree oil (Melaleuca oil), also known as Australian tea tree oil,may be derived from the leaves, root or plant of Melaleuca alternifoliaand, in a non-limiting embodiment contains more than 10% terpinene-4-olas measured by GC FID, ECD or other non-limiting method comparablethereto (GC: gas chromatography; FID: Flame Ionization Detector; ECD:Electron Capture Detector).

The Aloe gel, resin, latex or extract (aqueous or alcoholic extract) maybe derived from the leaves, root or plant of Aloe (including but notlimited to Aloe vera, Aloe africana, Aloe arborescens Miller, Aloebarbadensis, Aloe barbadesis, or Aloe capensis).

The Lavender oil may be derived from the leaves, flower, plant or rootof Lavandula officinalis, or another species of Lavender such as commonlavender, English lavender, garden lavender, Lavandula angustifolia,Lavandula burnamii, Lavandula dentate, Lavandula dhofarensis, Lavandulalatifolia, Lavandula officinalis, or Lavandula stoechas.

The present invention also contemplates compositions comprisingcomponents in addition to and outside the ranges provided above.

The composition described herein may also comprise additional componentsor extracts containing growth factors (such as from colostrum, whey,blood or tissue), antibiotics, analgesics, zinc oxide, vitamin A,vitamin E, or extracts of Harpagophytum procumens (Devil's claw) root,Salix Alba (White Willow) plant and/or bark, Tanacetum Parthenium(Feverfew) herb and/or flower, Equisetum arvense (Horsetail), Spireaeulmaria (Dropwort), Betula alba (Birch), Urtica dioica (StingingNettle), Curcumin extract, longa (Tumeric), marine algae, Gotu kola(Centella asiatica Linn.), total triterpenic fraction of Centellaasiatica (TTECA) or a combination thereof.

In addition, the composition described herein may comprise one or moreadditional non-plant component, for example, but not limited to Lanolin,petroleum jelly (e.g. Vaseline™), Paraffin oil, Zinc oxide, cod liveroil, vegetable oil, paraffinium liquid, and one or more preservative,for example, but not limited to hydroxybenzoates, or scent agents tocamouflage the odor of the formulation, for example, but not limited toessential oils of plants/flowers, or any combination thereof.

Without wishing to be limiting in any manner, the composition may beformulated into a suitable topical dosage form, for example, but notlimited to an ointment, lotion or cream that may be applied topically toa wound or site of skin injury as such. More preferably, the compositionis formulated into ointments for applying to wounds. For example, butnot wishing to be limiting in any manner, an ointment comprising 2% oilfrom the leaves of Melaleuca alternifolia (Tea Tree oil); 2.8% gum fromthe resin of Boswellia serrata (boswellia); 1% of a 10% gel from theleaves of Aloe vera (Aloe); 0.4% oil from the flower of Lavandulaofficinalis (Lavender), Lanolin, Zinc oxide, Cod Liver oil, ParaffinumLiquidum, Vaseline™ White, Propyl hydroxybenzoate, Methylhydroxybenzoate, and water can be prepared using standard proceduresknown in the art. The composition may also comprise additionalcomponents including, but not limited to, alginate, hydrocolloid and orother components.

In a further non-limiting embodiment of the invention, the plantointment is prepared by warming the lanolin (9 kg), Vaseline™ (9 kg) andparaffin (10 kg) together to +/−55° C. so the mix is a fluid liquid. Tenkg of a 22% concentrate of Boswellia serrata gum or resin, Tea Tree oil(Melaleuca oil), Aloe vera gel, and Lavender oil (Lavandula officinalis)is prepared and warmed to 30-35° C. and a clear liquid is obtained.After that, the first liquid is added in a tub (pit) with a mixer,thereafter the second liquid is added (warmed Lurax concentrate). In apreferred embodiment, the mixer is a high power mixer with sufficientpower to mix the reagents, although it does not have to turn quickly,similar to a dough-kneader. Once well mixed (e.g. after approximately10-15 minutes), approximately 7.2 kg of zinc oxide may be added. After 5minutes of further mixing, the warm ointment can be filled into acontainer.

In another non-limiting embodiment, there is provided a composition toobtain a wound dressing or wound foam comprising 2% oil from the leavesof Melaleuca alternifolia (Tea Tree oil); 2.8% gum from the resin ofBoswellia serrata (boswellia); 1% gel from the leaves of Aloe vera(Aloe); 0.4% oil from the flower of Lavandula officinalis (Lavender),Lanolin, Zinc oxide, Cod Liver oil, Paraffinum Liquidum, Vaseline™White, Propyl hydroxybenzoate, Methyl hydroxybenzoate, Water and anabsorptive agent such as, but not limited to, calcium alginate, chitosanor hydrocolloid (natural, chemically modified, and/or synthetichydrocolloids).

In a further embodiment, there is provided a composition comprising 2%oil from the leaves of Melaleuca alternifolia (Tea Tree oil); 2.8% gumfrom the resin of Boswellia serrata (boswellia); 1% gel from the leavesof Aloe vera (Aloe); 0.4% oil from the flower of Lavandula officinalis(Lavender), Lanolin, Zinc oxide, Cod Liver oil, Paraffinum Liquidum,Vaseline™ White, Propyl hydroxybenzoate, Methyl hydroxybenzoate, Waterand an absorptive agent such as, but not limited to, calcium alginate,chitosan or hydrocolloid (natural, chemically modified, and/or synthetichydrocolloids) and this composition is added to, coated or embedded intoa fibrous wound dressing, bandage or other type of dressing for applyingdirectly to wounds.

It is intended that the present invention includes additionalembodiments of the specific preparations and preparative methodsdescribed above. Variations according to the knowledge of one skilled inthe art such as by scale, i.e. by scaling-up or scaling-down thedescribed parameters. Further, the specified time and temperature rangesspecified above should be considered to be exemplary for the purpose ofenabling one to practice the invention, and therefore non-limiting.

The present invention also contemplates a method of treating wounds, sunburns, heat burns, skin injuries, insect bites, surgical incisionwounds, traumatic wounds, cracked heals, skin ulcers, diabetic ulcers,pressure ulcers or other skin injury conditions and the like byadministering a composition, ointment or dressing composition asdescribed herein to a subject in need thereof. In a preferredembodiment, which is not meant to be limiting in any manner, it isgenerally preferred that the composition, ointment or dressingcomposition, as described herein, be applied daily until the wound isclosed/healed.

Definitions:

A “dressing” is an adjunct used for application to a wound to promotehealing and/or prevent further harm. It is designed to be in directcontact with the wound. The dressing may be a piece of material, such ascloth or gauze, a film, a gel, a foam, chitin, a hydrocolloid, analginate, a hydrogel, or a polysaccharide paste, granules or beads.Dressings can be impregnated with any desired antiseptic chemicals, anagent designed to speed healing, or other active agent as is known inthe art or described herein.

A “bandage” is a piece of material used either to support a medicaldevice such as a dressing, or on its own to provide support to the body.Bandages may take a wide range of forms, from generic cloth strips, tospecialized shaped bandages designed for a specific limb or part of thebody. In certain embodiments, a “bandage” may also refer to a supportingmaterial and a dressing which is used directly on a wound.

“Chitin” is a polymer comprising units of N-acetyl-D-glucos-2-aminecovalently linked with β-1,4 linkages. Medical devices as describedherein may comprise chitin in order to take advantage of its propertiesas a flexible and strong material, as well as its biodegradability. Incertain embodiments, chitin may be incorporated into a dressing, orother non-limiting medical device.

A “hydrocolloid” is defined as a colloid system wherein the colloidparticles are dispersed in water. A hydrocolloid has colloid particlesspread throughout water, and depending on the quantity of wateravailable that can take place in different states, e.g., gel or sol(liquid). Hydrocolloids can be either irreversible (single-state) orreversible. Hydrocolloids can be derived from natural or syntheticsources. Non-limiting examples of natural hydrocolloids includeagar-agar, carrageenan, gelatin, and pectin. In hydrocolloid-basedmedical dressings, the hydrocolloid may interact with tissue fluid toform a nonadhesive gel.

“Alginate” is a salt of alginic acid, typically extracted from marinekelp. Certain alginates, including but not limited to calcium, sodium,and ammonium alginates, can be used in foam, cloth, or gauze forabsorbent surgical dressings.

The present invention will be further illustrated in the followingexamples.

EXAMPLES

Animal model: Groups of 8 ICR male mice weighing 22±2 g were used. Underether anesthesia, the shoulder and back region of each animal wasshaved. A sharp punch (ID 12 mm) was used to remove the skin includingpanniculus carnosus and adherent tissues. The wound area, traced ontoclear plastic sheets on days 3, 5, 7, 9 and 11, were quantitated by useof an Image Analyzer (Life Science Resources VISTA, Version 30). Testcompound and vehicle (20 μl, 1.5% carboxymethylcellulose in PBS) wereapplied topically immediately following injury and in single, two orthree applications daily thereafter for a total of 10 consecutive days.The wound half-closure time (CT₅₀) was determined and unpaired Student'st test was applied for comparison between treated and vehicle group ateach measurement time point. Differences are considered statisticalsignificance at P<0.05. CGS-21680((2-p-carboxyethyl)phenylamino-5′-N-carboxamidoadenosine) was used as apositive comparator.

Test substance C-T-1001 (Ointment A: herbal active ingredients tea treeoil, boswellia resin, aloe vera gel and lavender oil) was evaluated forpossible wound healing activity. The test substance was appliedtopically to the wound area once, twice, or three times daily for 10consecutive days. Percent closure of the wound (%) was determined ondays 3, 5, 7, 9 and 11 in order to generate the half closure time(CT50). One-way ANOVA followed by Dunnett's test was used to determinesignificant difference between the treated groups and vehicle control.It was concluded that topical administration of C-T-1001 at 20 mg/mousefor 10 consecutive days promoted significant increase in wound closureduring the observation period from day 7 to day 11, in proportion tofrequency of daily treatment; C-T-1001 at 20 mg/mouse 2 and 3 timesdaily, but not once a day treatment, was associated with a significantdecrease in CT50 value in the mouse model of cutaneous injury. Theresults are summarized in Table 1 and FIG. 1.

TABLE 1 Summary of animal test data The Closure of Wound (%) CT₅₀Treatment Route Dose Day 3 Day 5 Day 7 Day 9 Day 11 (Days) Vehicle TOP20 μl/mouse × 10 X 26.7 43.0 52.8 65.9 73.2 6.9 (1.5% CMC/PBS pH7.4) SEM3.4 3.0 2.2 1.9 1.9 0.3 C-T-1001 TOP 20 mg/mouse qd × 10 X 9.5 25.6 54.277.4* 88.3* 6.8 SEM 2.8 2.2 3.2 1.2 1.0 0.1 C-T-1001 TOP 20 mg/mouse bid× 10 X 13.7 37.2 63.6* 84.6* 91.0* 6.2* SEM 2.5 3.3 1.6 1.2 0.7 0.1C-T-1001 TOP 20 mg/mouse tid × 10 X 14.2 36.5 67.9* 86.0* 94.9* 6.0* SEM2.9 2.5 3.1 1.7 1.3 0.1 CGS-21680 TOP 10 μg/mouse × 10 X 42.4* 56.3*66.8* 74.3* 81.7* 5.5* SEM 1.7 1.5 2.3 1.3 0.6 0.1 The closure of thewound (%) and wound half-closure time (CT₅₀) were determined. One-wayANOVA followed by Dunnett's test was used for comparison between thetreated and vehicle groups. *P < 0.05, vs. vehicle.

Human Clinical Trial:

Summary—In a 30-day clinical trial, the benefits of several formulationsof the herbal active ingredients tea tree oil, boswellia resin, aloevera gel and lavender oil, on wound healing were assessed in six uniformwounds created by using a fractional CO₂ laser in over 30 healthy humanvolunteers. The formulations were compared and tested on each of theover 30 volunteers. The formulations were applied to wounds daily, andoccluded with a bandage dressing, for a period of 30 days. After oneweek of treatment, hydrophilic ointment formulations performedsignificantly better than Polysporin™ and Petrolatum for erythema,epithelialization, and maceration. Throughout the 30-day study (days 14,21) the hydrophilic ointment formulations performed better for erythema.In addition, the hydrophilic ointment formulations performed better thanPetrolatum and Polysporin™ for scarring and hyperpigmentation. The studyalso demonstrated that a higher degree of occlusion would ameliorate thehealing of the wound.

Clinical Trial Details—The 30-day controlled trial was conducted toassess the effects for five topically applied agents on wound healing insix uniform wounds created by using a CO₂ laser. At Baseline, onenegative control site and five test sites were marked on the ventralforearms (three sites per arm) and the Investigator created five uniformwounds, approximately 100 microns deep and 1 centimeter in diameter,using a fractional CO₂ laser set at a regular mode at the five testsites; the negative control site was not exposed to the laser. A totalof 31 human volunteers completed the study. Five formulations wereevaluated in this study. Ointment A: multi-herbal ointment that was morefluid than thick in consistency. Ointment B: multi-herbal ointment thatwas thick in consistency. Ointments A and B had the exact samequantities of active ingredients and non-medicinal ingredients and theonly difference was the blending method that made the ointment thicker.Ointment A and ointment B contained the herbal active ingredients teatree oil, boswellia resin, aloe vera gel and lavender oil. Cream C:multi-herbal topical formulation that also contained the exact samequantity of active ingredients as ointments A and B but it did notcontain the same non-medicinal ingredients. Cream C is a hydrophilicformulation. Formulation D: a commercial preparation of Petrolatum.Formulation E: Polysporin™.

After Baseline evaluations, the human volunteers applied theformulations twice daily to the assigned test (the control site was leftuntreated) site and subsequently (each time) an adhesive bandage wasapplied over the wound site.

Evaluations were conducted, blinded by the investigator, at Day 1, Day4, Day 7, Day 14, Day 21, and Day 30. At baseline and Days 1, 4, 7, 14and 21, evaluations consisted of: grading for erythema, edema,epithelialization, maceration and scabbing. On Day 30, the wounds werevisually graded for Scar Formation (Scar Formation (0=healthy, normalskin and 10=keloid, hypertrophic, or other scar present) andPost-Inflammatory Hyperpigmentation (Post-Inflammatory Hyperpigmentation(0=none and 10=severe).

Overall, after one week of treatment, ointments A and B performed betterthan formulations D and E for erythema, epithelialization, andmaceration. At Days 14 and 21, the ointments A and B continued toperform better for erythema. Formulations D and E performed better thanointments A and B for scabbing and hydration, starting after two weeksof treatment. This was due to the highly occlusive nature of testformulations D and E (Petrolatum and Polysporin™, respectively).

Mean values for clinical grading at each time point (Days 1, 4, 7, 14,21 and 30) were statistically compared to mean Baseline values usinganalysis of variance (ANOVA) with pair-wise comparisons (Fisher's LSD)and paired t-tests at the p≦0.05 significance level. Mean percent changefrom Baseline and incidence of positive responders were calculated forall attributes.

The results are presented in Table 2 below. It should be noted that theCream C was discontinued from the study due to poor healing during thefirst week of treatment. The results provided are only for Ointments Aand B and Formulations D and E.

TABLE 2 Mean Values For Clinical Grading Baseline Day 1 Day 4 Day 7 Day14 Day 21 Treatment (n = 31) (n = 31) (n = 31) (n = 31) (n = 31) (n =30) Erythema A 1.87 2.16 2.94 ◯ 3.48 ◯ 3.84 ◯ 3.77 ◯ B 1.97 2.48 2.74 ◯3.26 ◯ 3.84 ◯ 4.07 ◯ D 2.10 2.58 3.32 ◯ 4.32 ◯ 5.35 ◯ 5.30 ◯ E 2.10 2.81◯ 3.39 ◯ 4.61 ◯ 5.06 ◯ 4.98 ◯ Edema A 0.00 0.23 0.23 ◯ 0.19 ◯ 0.16 0.12B 0.00 0.23 ◯ 0.42 ◯ 0.10 0.13 0.00 D 0.06 0.19 0.55 ◯ 0.55 ◯ 0.35 ◯0.12 E 0.00 0.29 ◯ 0.39 ◯ 0.39 ◯ 0.16 0.03 Epithelialization A 0.00 0.90 2.32  3.48  5.55  6.65  B 0.00 0.71  2.06  3.58  5.84  6.83 D 0.00 0.68  2.06  2.68  5.61  6.33  E 0.00 0.71  2.45  2.81 5.45  6.68  Maceration A 0.00 0.52 ◯ 1.45 ◯ 1.13 ◯ 0.19 0.07 B 0.000.58 ◯ 1.61 ◯ 0.90 ◯ 0.16 0.07 D 0.00 0.68 ◯ 1.90 ◯ 1.26 ◯ 0.26 ◯ 0.43 E0.00 0.45 ◯ 1.39 ◯ 1.65 ◯ 0.35 ◯ 0.30 Scabbing A 0.00 0.00 0.13 0.94 ◯2.55 ◯ 1.32 ◯ B 0.00 0.00 0.19 0.84 ◯ 1.97 ◯ 1.02 ◯ D 0.00 0.00 0.231.26 ◯ 1.45 ◯ 0.60 ◯ E 0.00 0.00 0.00 0.71 ◯ 1.97 ◯ 0.60 ◯  Indicates astatistically significant (p ≦ 0.05) improvement compared to Baseline ◯Indicates a statistically significant (p ≦ 0.05) worsening compared toBaseline

Comparisons, based on the average change from the Baseline, were madeamong the test sites using analysis of variance (ANOVA) with pair-wisecomparisons (Fisher's LSD). The rankings shown in Table 3 below arepresented from the least to the greatest level of change, which ispresented in parentheses. Statistically significant (p≦0.05) differencesbetween the test materials appear below, and items marked by the sameline are not significantly different from one another.

TABLE 3 Comparisons Among Test Sites Based On The Average Change FromThe Baseline

Outcome of Human Study:

-   -   Test Ointments A and B performed better than Formulations D and        E for erythema on Days 7, 14 and 21    -   Test Ointments A and B performed better than Formulations D and        E for epithelialization on Day 7    -   Test Ointments A and B performed better than Formulation E for        maceration on Day 7    -   Test Formulation D performed better than A for scabbing on Day        14    -   Test Formulations D and E performed better than Ointment A for        scabbing on Day 21

Overall, after one week of treatment, test Ointments A and B performedbetter than D and E for erythema, epithelialization, and maceration.With extended treatment, test Ointments A and B continued to performbetter for erythema.

Test Formulations D and E performed better than A and B for scabbing,starting after two weeks of treatment. This result is due to the highlyocclusive nature of test Formulations D and E (Petrolatum andPolysporin™, respectively) and therefore suggests the application of theherbal formulation using semi and full-occlusive devices such asbandages, dressings, etc, as described herein.

REFERENCES

-   1. Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing.    Clinics in Dermatology 2007, 25: 9-18.-   2. Montesinos, M. C., Gadangi, P., Longaker, M., Sung, J., Levine,    J., Nilsen, D., Reibman, J., Li, M., Jiang, C. K., Hirschom, R.,    Recht, P. A., Ostad, E., Levin, R. I. and Crostein, B. N. Wound    healing is accelerated by agonists of Adenosine A ₂ (Gα _(s)-linked)    receptors. J. Exp. Med. 186: 1615-1620, 1997.-   3. Heggers J P, Pelley R P, Robson M C. Beneficial effects of Aloe    in wound healing. Phytotherapy Research 1993; 7: S48-52.-   4. Heggers J P, Kucukcelebi A, Listengarten D, et al. Beneficial    effects of Aloe on wound healing in an excisional wound model. J    Altern Complem Med 1996; 2:271-8.-   5. Lansdown A B, Mirastschijski U, Stubbs N, Scanlon E, Agren M S.    Zinc in wound healing: theoretical, experimental, and clinical    aspects. Wound Repair Regen. 2007 January-February; 15(1):2-16.-   6. Denis Okan, Kevin Woo Elizabeth A. Ayello R. Gary Sibbald. The    Role of Moisture Balance in Wound Healing Adv Skin Wound Care 2007;    20:39-53; quiz 54-5.-   7. Terkelsen L H, Eskild-Jensen A, Kjeldsen H, Barker J H, Hjortdal    V E. Topical application of cod liver oil ointment accelerates wound    healing: an experimental study in wounds in the ears of hairless    mice. Scand. J Plast. Reconstr. Surg. Hand Surg. 2000; 34:15-20.

1. A composition comprising Boswellia gum, gel, resin or extract, Tea Tree oil (Melaleuca oil), an Aloe gel, resin, latex or extract and Lavender oil.
 2. The composition according to claim 1, wherein the Boswellia gum, gel, resin or extract is obtained from leaves, plant or roots of Boswellia serrata, Boswellia sacra or Boswellia carterii.
 3. The composition according to claim 1, wherein the composition comprises about 10% to 99% boswellic acids derived from the Boswellia gum, gel, resin or extract.
 4. The composition according to claim 1, wherein the composition comprises about 50% to 79% boswellic acids.
 5. The composition according to claim 1, wherein the Tea Tree oil is obtained from leaves, root or plant of Melaleuca alternifolia.
 6. The composition according to claim 1, wherein the Tea Tree oil contains more than about 10% terpinene-4-ol.
 7. The composition according to claim 1, wherein the Aloe gel, resin, latex or extract is obtained from the leaves, root or plant of Aloe vera, Aloe africana, Aloe arborescens Miller, Aloe barbadensis, Aloe barbadesis, Aloe capensis or combinations thereof.
 8. The composition according to claim 7, wherein the Aloe extract is an aqueous or alcoholic extract.
 9. The composition according to claim 1, wherein the Lavender oil is obtained from the leaves, root, flower or plant of Lavandula officinalis, common lavender, English lavender, garden lavender, Lavandula angustifolia, Lavandula burnamii, Lavandula dentate, Lavandula dhofarensis, Lavandula latifolia, Lavandula officinalis, Lavandula stoechas or combinations thereof.
 10. The composition according to claim 1, further comprising one or more component or extract containing growth factors; an antibiotic; an analgesic; zinc oxide; vitamin A; vitamin E; an extract of Harpagophytum procumens (Devil's claw) root, Salix Alba (White Willow) plant and/or bark, Tanacetum Parthenium (Feverfew) herb and/or flower, Equisetum arvense (Horsetail), Spireae ulmaria (Dropwort), Betula alba (Birch), Urtica dioica (Stinging Nettle), Curcumin, longa (Tumeric), marine algae or Gotu kola (Centella asiatica Linn.); total triterpenic fraction of Centella asiatica (TTECA); or combinations thereof.
 11. The composition according to claim 10, wherein the component or extract containing growth factors comprises colostrum, whey, blood, tissue, or combinations thereof.
 12. The composition according to claim 1, further comprising one or more components to absorb wound exudates, slowly release the active agents or both.
 13. The composition according to claim 12, wherein the one or more components to absorb wound exudates, slowly release the active agents or both is selected from the group consisting of alginate, chitosan, hydrocolloid, chitin, polyoligosaccharide, liposome, a slow-releasing polymer or agent, and combinations thereof.
 14. The composition of claim 13, wherein the hydrocolloid comprises a natural, chemically modified, or synthetic hydrocolloid, or a combination thereof
 15. The composition of claim 13, wherein the alginate comprises calcium alginate.
 16. The composition of claim 1, further comprising one or more non-plant component selected from the group consisting of Lanolin, petroleum jelly, Paraffin oil, Zinc oxide, cod liver oil, vegetable oil, and paraffinium liquid.
 17. The composition of claim 1, further comprising one or more preservative.
 18. The composition of claim 17, wherein the preservative is a hydroxybenzoate.
 19. The composition of claim 1, further comprising one or more scent agent to camouflage the odour of the composition.
 20. The composition of claim 19, wherein the scent agent comprises an essential oil of a plant, flower, or combination thereof.
 21. The composition of claim 1, formulated into a topical ointment, lotion or cream comprising about 2% oil from the leaves of Melaleuca alternifolia (Tea Tree oil); about 2.8% gum from the resin of Boswellia serrata (boswellia); about 1% of a 10% gel from the leaves of Aloe vera (Aloe); and about 0.4% oil from the flower of Lavandula officinalis (Lavender).
 22. The composition of claim 21, further comprising Lanolin, Zinc oxide, Cod Liver oil, Paraffinum Liquidum, white petroleum jelly, Propyl hydroxybenzoate, Methyl hydroxybenzoate and water.
 23. The composition of claim 22, further comprising an alginate, a hydrocolloid, or combinations thereof.
 24. The composition of claim 1, wherein the Boswellia gum, gel, resin or extract, the Tea Tree oil (Melaleuca oil), the Aloe gel, resin, latex or extract and the Lavender oil are combined in a ratio of about 2:2.8:1:0.4, respectively, of the Boswellia gum, gel, resin or extract, the Tea Tree oil (Melaleuca oil), the Aloe gel, resin, latex or extract and the Lavender oil.
 25. The composition of claim 24, wherein the Aloe gel, resin, latex or extract is a 10% gel.
 26. The composition of claim 1, added to, coated on or embedded into a wound dressing or bandage.
 27. The composition of claim 26, wherein the wound dressing is a fibrous wound dressing or a dressing for applying directly to wounds for occlusion or semi-occlusion.
 28. The composition of claim 1, formulated within or on the surface of a medical device.
 29. The composition of claim 28, wherein the medical device is a dressing, a bandage, or other semi-occlusive or occlusive material used in wound care.
 30. A medical device comprising the composition as defined in claim 1, coated thereon or embedded within said medical device.
 31. The medical device of claim 30, wherein the composition is contained at least partially within particles or microparticles.
 32. The medical device of claim 31, wherein the particles or microparticles are liposomes.
 33. The medical device of claim 31, wherein the particles or microparticles comprising the composition are used to deliver or release active ingredients to the wound while maintaining semi-occlusion or complete occlusion.
 34. The medical device of claim 30, wherein the medical device is a dressing, a bandage, or other semi-occlusive or occlusive material used in wound care.
 35. A method of treating sores, wounds, burns or other traumatized dermal tissues and skin injuries, comprising administering a composition as defined in claim 1 to a subject in need thereof.
 36. The method of claim 35, wherein the composition is applied daily until there is at least partial healing or amelioration of the sore, wound, burn or other traumatized dermal tissue or skin injury.
 37. The method of claim 35, wherein the method comprises treating acute wounds selected from the group consisting of heat burns, sun burns, traumatic injuries, surgical wounds, punctures, cracked heals, bites, insect bites and infected wounds.
 38. The method of claim 35, wherein the method comprises treating chronic wounds selected from the group consisting of venous leg ulcers, pressure sores or ulcers, ischemic ulcers and diabetic ulcers.
 39. The method of claim 35, wherein the subject is a mammal.
 40. The method of claim 39, wherein the mammal is a human.
 41. A method of preparing a composition for treating sores, wounds, burns or other traumatized dermal tissues and skin injuries, comprising the steps of a. combining lanolin, petroleum jelly and paraffin and mixing until a first fluid liquid is obtained, b. combining Boswellia gum, gel, resin or extract, Tea Tree oil (Melaleuca oil), an Aloe gel, resin, latex or extract and a Lavender oil and warming until a second clear liquid is obtained, c. combining and mixing the first and second liquids to obtain said composition.
 42. The method according to claim 41, further comprising the step of filling one or more containers with said composition.
 43. The method of claim 41, wherein step (a) comprises combining about 9 kg lanolin, about 10 kg petroleum jelly and about 10 kg paraffin.
 44. The method according to claim 41, wherein step (a) further comprises warming the lanolin, petroleum jelly and paraffin to about 55° C.
 45. The method according to claim 41, wherein step (b) comprises combining about 10 kg of a 22% concentrate of Boswellia serrata gum or resin, the Tea Tree oil (Melaleuca oil), Aloe vera gel, and Lavandula officinalis oil.
 46. The method according to claim 41, wherein step (b) further comprises warming the Boswellia gum, gel, resin or extract, the Tea Tree oil (Melaleuca oil), the Aloe gel, resin, latex or extract and the Lavender oil to about 30-35° C.
 47. The method according to claim 41, wherein in step (c) the first and second liquids are mixed for about 10-15 minutes.
 48. The method according to claim 41, further comprising a step of adding zinc oxide during or after step (c).
 49. The method of claim 48, wherein about 7.2 kg of the zinc oxide is added, followed by about 5 minutes mixing.
 50. The invention as herein described. 